Apparatus, system and method for manipulating a surgical catheter and working device with a single hand

ABSTRACT

Systems and methods are disclosed that include a guide catheter apparatus insertable through a external body passage of a subject. The guide catheter apparatus includes a substantially rigid shaft and a handle. The shaft has a proximal opening, a distal opening, and a lumen extending between the proximal opening and the distal opening. The handle has a structure to allow a position of the guide catheter to be controlled by some or all of three fingers of one hand of an operator of the handle. The structure of the handle is adapted to permit the operator to position a thumb and index finger of the hand to manipulate a working device inserted into the lumen of the guide catheter, where the working device is manipulable via a portion of the working device immediately adjacent to the handle.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/691,438 filed Apr. 20, 2015, now U.S. Pat. No. 10,413,714, which is acontinuation of U.S. application Ser. No. 12/454,560 filed May 18, 2009,now U.S. Pat. No. 9,011,412, which claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/127,848 filed May16, 2008, all of which are incorporated herein by reference in theirentirety as if fully set forth herein.

TECHNICAL FIELD

The present invention is generally directed to surgical devices and, inparticular, to an apparatus, system and method for manipulating asurgical catheter and working device with a single hand.

BACKGROUND

FIG. 1 presents a schematic diagram of a typical surgical catheter (orguide) 100 that may be used to perform a procedure in a nasal,sinonasal, or oral passage or other external body passage. The catheter100 includes a tube 102 having therein a duct 104. The tube 102 may beintroduced into the body passage and a guidewire or other working deviceinserted into the duct 104 via an opening 106 at a proximal end of thecatheter 100. The duct 104 then operates to guide the working device toan opening 108 at a distal end of the tube 102. A handle 110 may beformed into or attached to the proximal end of the tube 102 to permitpositioning of the catheter 100 by movement of the catheter 100 into andout of the body passage and rotation of the catheter 100 around alongitudinal axis with a first hand. Once a desired position isobtained, the catheter 100 with fingers of a second hand that alsograsps an endoscope and held in position. The first hand may then beused to manipulate the working device inserted into the duct 104.

SUMMARY OF THE INVENTION

This disclosure provides an apparatus, system and method formanipulating a surgical catheter and working device with a single hand.

In one embodiment, a system includes a guide catheter, a working deviceand a handle coupled to the guide catheter. The guide catheter isinsertable through an external body passage of a subject, and includes asubstantially rigid shaft, a proximal opening, a distal opening and alumen extending between the proximal opening and the distal opening. Theworking device is adapted to be insertable through the lumen of theguide catheter. The handle has a structure that allows a position of theguide catheter to be controlled by some or all of three fingers of onehand of an operator of the handle. The structure of the handle isadapted to permit the operator to position a thumb and index finger ofthe hand to manipulate the working device via a portion of the workingdevice that is immediately adjacent to the handle.

In another embodiment, a method includes inserting a guide catheterthrough an external body passage of a subject, inserting a workingdevice through the lumen of the guide catheter, and controlling aposition of the guide catheter using a handle affixed to the guidecatheter while substantially simultaneously manipulating the workingdevice. The position of the guide catheter is controlled by some or allof three fingers of a hand and a thumb and index finger of the handmanipulate the working device via a portion of the working deviceimmediately adjacent to the handle.

In still another embodiment, a guide catheter apparatus insertablethrough a external body passage of a subject includes a substantiallyrigid shaft and a handle. The shaft has a proximal opening, a distalopening, and a lumen extending between the proximal opening and thedistal opening. The handle has a structure to allow a position of theguide catheter to be controlled by some or all of three fingers of onehand of an operator of the handle. The structure of the handle isadapted to permit the operator to position a thumb and index finger ofthe hand to manipulate a working device inserted into the lumen of theguide catheter, where the working device is manipulable via a portion ofthe working device immediately adjacent to the handle.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention and itsadvantages, reference is now made to the following description taken inconjunction with the accompanying drawings, in which:

FIG. 1 presents a schematic diagram of a surgical catheter;

FIG. 2 presents a schematic diagram of a surgical catheter according tothis disclosure;

FIG. 3 presents a schematic diagram of another surgical catheteraccording to this disclosure;

FIG. 4 presents a schematic diagram of a surgical catheter according tothis disclosure with working devices inserted;

FIG. 5 presents a schematic diagram of a surgical catheter according tothis disclosure held by a user; and

FIG. 6 presents a schematic diagram of still another surgical catheteraccording to this disclosure.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIG. 2 depicts a schematic diagram of a surgical catheter 200 accordingto the present disclosure. The catheter 200 includes a tube 202 havingtherein a duct 204 with an opening 208 at a distal end. A handle 210 maybe formed into or attached to the proximal end of the tube 202. AY-shaped section 212 is coupled to a proximal end of the tube 202 at adistal end of the section 212. The section 212 includes a second handle218 and an opening 216 at a proximal end of the section 212. The section212 includes a duct 214 that mates with the duct 204 of the tube 202. Asdescribed for the catheter 100, working devices may be inserted in theopening 216 and guided to the opening 208 at the distal end of the tube202 by the duct 214 and the duct 204.

The section 212 further includes a branch section 212A having a branchduct 214A. Suction may be applied to the catheter 200 via the branchsection 212A. Where both the opening 216 and the opening 208 are leftuncovered, the suction will be conducted to the opening 216 via theducts 214A and 214 and to the opening 208 via the ducts 214A, 214 and204. Because the tube 202 is inserted into a body passage and, possibly,through a hole in a membrane of the body, the opening 208 may be sealedoff from the ambient air pressure outside the catheter 200. In such asituation, the suction applied to the branch section 212A will primarilyresult in air being drawn through the opening 216 and into the duct214A.

Partially or completely blocking the opening 216, however, will resultin the suction drawing blood, mucous, and other materials into theopening 208 and along the ducts 204, 214 and 214A, resulting in removalof the materials from the vicinity of the distal end of the tube 202. Anoperator of the catheter 200 may vary the mount of blockage of theopening 216 with a finger or valve, in order to control the amount ofsuction delivered to the opening 208. In this way, materials produced bythe body in response to operation of the working devices (or freed fromthe body by the operation of the working devices) may be removed fromvicinity of the distal end of the tube 202 by way of a controlled amountof suction. Such removal may provide a clearer view for an endoscopeinserted into the catheter 200, a clearer working area for a cutter, orother similar benefits.

A coupling 220 at a proximal end of the branch section 212A couples atube 222 having a duct 224 to the branch section 212A and the duct 214A,respectively. The tube 222 may conduct the suction to the section 212from a suction canister or other suction source. Where the tube 222 isstiff, the coupling 220 may permit rotation of the branch section 212Arelative to the tube 222, to reduce interference by the tube 222 with anoperator's positioning of the catheter 200.

In another embodiment, a coupling 226 at a proximal end of the tube 222may couple a second tube 228 having a duct 230 to the tube 222 and theduct 224, respectively. The coupling 220 does not permit rotation of thetube 222 relative to the branch section 214A, nor does the coupling 226permit rotation of the tube 228 relative to the tube 222. However, wherethe tube 228 is stiff, a flexible tube 222 may be employed to reduceinterference by the tube 228 with an operator's positioning of thecatheter 200.

While the section 212 is shown and described as separate from the tube202, it will be understood that in other embodiments, the section 212may be formed integrally with the tube 202. In still other embodiments,the coupling 220 may be mounted directly to a side of the section 212,rather than to the branch section 212A. While the section 212 is shownfixedly attached to the tube 202, in other embodiments the section 212may move relative to the tube 202, in order to further free tetheringand increase a user's free and unencumbered movements in space, whileleaving the tube 202 in a substantially fixed position relative to thepatient's body. In such embodiments, the section 212 may rotate freelyor be moved to a desired position and then locked into place via asuitable locking mechanism.

FIG. 3 presents a schematic diagram of a second surgical catheter 300according to the disclosure. The catheter 300 includes a body having ahandle 350. At a distal end of the catheter 300 is a guide coupling 310,which may be a rotating ‘female’ luer lock. The guide coupling 310accepts and locks a guide 302. The coupling also operates to permit theguide 302 to be rotated to a desired position relative to the handle 350and locked in that position for use. The guide coupling 310 may includedetents to allow the guide 302 to be positioned only at predeterminedpositions relative to the handle 350.

The handle 350 may include concavities 356 adapted to provide a securegrip on the handle 350 by some or all of the middle, ring and littlefingers of a user's hand, as will be described in greater detail withreference to FIG. 5. The handle 350 may include a protrusion 352 adaptedto a secure grip on the handle 350 by a user when the upper portion ofthe handle 350 is positioned between the middle and ring fingers whilegrasping the lower portion of the handle 350 with the ring and littlefingers.

The handle 350 includes a duct 314 that passes from the guide coupling310 to an opening 318 at a distal end of the handle 350. The duct 314 isaligned with a duct in the guide 302 when the guide 302 is mounted inthe guide coupling 310, so that an endoscope, guidewire or other workingdevice may be inserted into the opening 318, pass through the duct 314and the guide 302 to emerge from a distal end of the guide 302. A branchsection 314 a of the duct 314 extends through the handle 350 to a handlecoupling 320. A source of suction may be attached to the handle 350 atthe handle coupling 320 to provide suction at the distal end of theguide 302, as described with reference to FIG. 2.

Where the opening 318 is provided with a one-way valve to prevent airbeing drawn into the opening 318 by suction in the branch section 314 a,an opening 354 may be provided between the branch section 314 a and theexterior of the handle 350 to allow the user to control the amount ofsuction present at the distal end of the guide 302.

The handle 350 may be provided with a locking screw 358. Once a user hasinserted a guide catheter through the duct 314 to a desired positionwithin the patient, the user may operate the locking screw 358 to holdthe guide wire in position while inserting another working device, suchas a balloon catheter, along the guide wire. Once the second workingdevice reaches the position of the locking screw 358, the locking screw358 may be operated to withdraw it from the duct 314 and allow thesecond working device to continue along the duct 314.

With reference to FIG. 4, a balloon catheter 454 has been inserted intothe opening 318 and through the guide 302. The balloon catheter 454includes a tube 452 coupled to an inflation device. Operation of theinflation device causes an inflation segment 456 of the balloon catheter454 to inflate. The handle 350 may be designed so that the distancebetween the opening 318 and the guide coupling 310 (indicated by theletter a), when added to the length of the guide 302 (indicated by theletter b), totals less than the distance between the attachment of thetube 452 at a proximal end of the balloon catheter 454 and the inflationsegment 456 (indicated by the letter c).

Furthermore, the distance between the opening 318 and the guide coupling310 may be selected based upon a distance between a shoulder feature ofthe proximal end of the balloon catheter 454 and the inflation segment456. The distance may be selected to allow the shoulder feature toengage the opening 318 while the inflation segment 456 extends past thedistal end of the guide 302 substantially only far enough to inflatewithout interference from the distal end of the guide 302. In this way,motion of the inflation segment 456 towards or away from the guide 302during inflation may be minimized to reduce the likelihood that theinflation segment 456 will slip out of position when inflated.

A suction tube 428 may be attached to the handle coupling 320 by a tubecoupling 422. Where the suction tube 428 is stiff, the tube coupling 422(or the handle coupling 320) may be flexible and/or rotate to reduceinterference by the stiff tube 428 with positioning the surgicalcatheter 300.

FIG. 5 illustrates the surgical catheter 300 in use. A surgeon or otheruser holds the handle 350 in a hand by some or all of the small finger,the ring finger and the middle finger. Gripped in this way, the surgeonmay move the guide 302 in the direction of its longitudinal axis, mayrotate the guide 302 about its longitudinal axis, or may rotate theguide 302 about an axis other than its longitudinal axis (‘yaw’). Thefore finger and thumb are left free to manipulate a working deviceinserted into the opening 318 or to cover the opening 318 to redirectsuction to the distal end of the guide 302, as described with referenceto FIG. 2. As described with reference to FIG. 4, flexibility and/orrotation of the couplings 320 and/or 422 may reduce the interference ofa stiff suction tube 428 on such motion.

The lower portion of the handle 350, which is grasped by the fingers,makes an angle with the upper portion of the handle, and with the guide302, that facilitates the user's manipulation of working devices withthe thumb and forefinger of a hand while grasping the handle with someor all of the remaining fingers of the hand. That is, the angle may beselected to place the user's thumb and forefinger in comfortableproximity to the opening 318, and the handle shaped to permit easymotion of the thumb and forefinger towards and away from the opening 318while securely grasping a working device inserted through the handle 350into the guide 302. As shown in the figures, that angle may beapproximately sixty (60) degrees, although other angles that are lessthan ninety (90) degrees and more than zero (0) degrees may be employed.

Using the handle 350, the user is enabled to control the position of theguide 302 by positioning the arm and wrist of the hand that is graspingthe handle, while simultaneously controlling the position of a workingdevice inserted into the guide 302 with the thumb and forefinger of thesame hand. This leaves the user's other hand free for other activities,such as holding an endoscope in position to view the distal ends of theguide 302 and the working device. In this way, the user is able tosimultaneously control the position of the distal end of the guide 302adjacent to a desired region of the patient and manipulate the workingdevice with one hand.

FIG. 6 illustrates a handle 650 according to the present disclosurewherein the upper portion of the handle 650 comprises a pivot 652. Theupper portion includes an opening 618 and a main duct and guide coupling(not shown, but similar to the duct 314 and the guide coupling 310) arein a fixed position relative to each other and to the pivot 652. Theduct branch in the handle 650 (not shown, but similar to the branch duct314 a) is pivotally coupled to the main duct, to allow suction appliedto a handle coupling 620 to be applied to the opening 318 and a guideattached to the guide coupling. The pivot 652 allows the handle 650 tobe rotated to a desired angular position relative to the upper portionand locked into the desired position.

Although the present invention and its advantages have been described inthe foregoing detailed description and illustrated in the accompanyingdrawings, it will be understood by those skilled in the art that theinvention is not limited to the embodiment(s) disclosed but is capableof numerous rearrangements, substitutions and modifications withoutdeparting from the spirit and scope of the invention as defined by theappended claims.

What is claimed is:
 1. A surgical catheter adapted to facilitatemanipulation of a guide and a working device with a single hand, thesurgical catheter comprising: a handle having an upper portion and alower portion; the upper portion of the handle having a working-deviceopening at a proximal end thereof and a guide coupling at a distal endthereof; the lower portion of the handle having a handle couplingextending therefrom and concavities on a surface thereof, theconcavities being disposed between the handle coupling and the guidecoupling to facilitate gripping of the handle by fingers of one hand ofan operator of the handle, the handle coupling being configured tocouple to a source of suction; a guide having a proximal guide openingat a proximal end, a distal guide opening at a distal end, and a guideduct extending from the proximal guide opening to the distal guideopening, the proximal end of the guide having at least three protrusionsaround a periphery thereof and spaced from the proximal guide opening,the proximal end of the guide being configured to be inserted into theguide coupling such that the at least three protrusions are at leastpartially inserted into the guide coupling; a Y-shaped section disposedwithin the handle, the Y-shaped section having a working-device sectionand a branch section, the working-device section having a first openingat a proximal end thereof, a second opening at a distal end thereof, anda working-device duct extending from the first opening to the secondopening; wherein the working-device duct is generally aligned with theguide duct when the guide is inserted in the guide coupling, such that aworking device may be inserted into the first opening of the Y-shapedsection, pass through the working-device duct and the guide duct toemerge from the distal end of the guide; the branch section having athird opening and a branch duct extending from the third opening to theworking-device duct, the third opening being coupled to the handlecoupling and configured to couple the source of suction to theworking-device duct to provide suction at the distal end of the guide;wherein the handle is adapted to permit the operator to grip the lowerportion of the handle using fingers of the one hand while simultaneouslypositioning a thumb or forefinger of the one hand to manipulate theworking device via a portion of the working device immediately adjacentthe upper portion of the handle; a balloon catheter inserted into thefirst opening of the Y-shaped section and through the guide when theguide is inserted in the guide coupling, the balloon catheter having aninflation segment at a distal end thereof; wherein the balloon catheterincludes an inflation tube coupled to the balloon catheter at a shoulderfeature, the inflation tube configured to be coupled to an inflationdevice such that operation of the inflation device causes the inflationsegment of the balloon catheter to inflate; and wherein the handle isconfigured such that the operator may manipulate the inflation segmentof the balloon catheter relative to the distal end of the guide bymoving the shoulder feature towards or away from the working-deviceopening and manipulate the working device via a portion of the workingdevice disposed between the shoulder feature and the working-deviceopening.
 2. The surgical catheter of claim 1, wherein the handle isconfigured such that a first distance between the working-device openingand the guide coupling, when added to a length of the guide extendingfrom the guide coupling when the guide is inserted therein, totals lessthan a second distance between the shoulder feature and the inflationsegment of the balloon catheter.
 3. The surgical catheter of claim 1,wherein a longitudinal axis of the guide forms an angle of more thanzero degrees with a longitudinal axis of the handle coupling extendingfrom the lower portion of the handle.
 4. The surgical catheter of claim1, wherein the working device may be moved relative to the guide, whileleaving the guide in substantially fixed position relative to apatient's body.
 5. The surgical catheter of claim 1, wherein the handleincludes at least one protrusion to facilitate the operator securing thehandle.
 6. The surgical catheter of claim 1, wherein the wherein theguide coupling operates to permit the guide to be rotated to a desiredposition relative to the handle and lock the guide in the desiredposition for use.
 7. The surgical catheter of claim 1, wherein the atleast three protrusions are at least partially inserted into the guidecoupling to allow the guide to be positioned only at predeterminedpositions relative to the handle.
 8. The surgical catheter of claim 1,wherein the concavities are adapted to provide a secure grip on thehandle by some or all of the middle, ring, and little fingers of the onehand of the operator.
 9. A surgical catheter comprising: a guide havinga guide opening at a distal end thereof, a proximal edge at a proximalend thereof, and a guide duct extending from the proximal end to thedistal end, wherein the proximal end has one or more protrusions arounda periphery thereof, the one or more protrusions being spaced from theproximal edge of the proximal end; a handle having a guide coupling at adistal end thereof that accepts and locks the proximal end of the guide,wherein the guide coupling operates to permit the guide to be rotated toa desired position relative to the handle and then locked in thatposition for use; wherein, when the proximal end of the guide isinserted into the guide coupling, the one or more protrusions are atleast partially inserted into the guide coupling to allow the guide tobe positioned only at predetermined positions relative to the handle; aY-shaped section disposed within the handle, the Y-shaped section havinga first opening at a proximal end thereof, a second opening at a distalend thereof, a working-device duct extending from the first opening tothe second opening, and a branch duct extending from the working-deviceduct to a third opening at an end of a branch section of the Y-shapedsection; wherein the working-device duct is generally aligned with theguide duct when the guide is inserted in the guide coupling, such that aworking device may be inserted into the first opening of the Y-shapedsection, pass through the working-device duct and the guide duct toemerge from the distal end of the guide; wherein the third opening ofthe Y-shaped section is coupled to a handle coupling protruding from alower portion of the handle, the handle coupling being configured to becoupled to a source of suction to provide suction at the distal end ofthe guide via the branch duct, the working-device duct, and the guideduct; a balloon catheter inserted into the first opening of the Y-shapedsection and through the guide when the guide is inserted in the guidecoupling, the balloon catheter having an inflation segment near a distalend thereof; wherein the balloon catheter includes an inflation tubecoupled to the balloon catheter at a shoulder feature, the inflationtube configured to be coupled to an inflation device such that operationof the inflation device causes the inflation segment of the ballooncatheter to inflate; and wherein the handle is configured to permit anoperator to grip the lower portion of the handle using fingers of onehand and position a thumb or forefinger of the one hand to move theshoulder feature towards or away from the working-device opening. 10.The surgical catheter of claim 9, wherein a lower surface of the handlehas concavities disposed between the handle coupling and the guidecoupling to facilitate gripping of the handle by the fingers of the onehand of the operator of the handle.
 11. The surgical catheter of claim9, wherein the handle is configured to permit the operator to manipulatethe working device via a portion of the working device disposed betweenthe shoulder feature and the working-device opening.
 12. The surgicalcatheter of claim 9, wherein the handle is configured to permit theoperator move the working device relative to the guide using the thumbor the forefinger of the one hand while leaving the guide insubstantially fixed position relative to a patient's body.